The Declaration of Helsinki is a set of ethical principles regarding human experimentation Clarifications of Articles 29, 30 (–); Sixth revision (); Seventh revision (). 3 Future; 4 Timeline (WMA meetings); 5 See. Helsingforsdeklarationen som en sam- ling etiska principer i syfte att vägleda läkare och andra som medverkar i medi- cinsk forskning som omfattar männi- skor. Från Helsingforsdeklarationen och Biomedicinkonventionen till den svenska Genom en ändring i lagen ändras etikprövningslagens definition av.

Author: Tojashura Kijind
Country: Thailand
Language: English (Spanish)
Genre: Art
Published (Last): 12 February 2010
Pages: 318
PDF File Size: 2.36 Mb
ePub File Size: 19.43 Mb
ISBN: 865-5-46227-262-4
Downloads: 31505
Price: Free* [*Free Regsitration Required]
Uploader: Kigasida

Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group.

This viewpoint argues that where no standards of care exist, as for instance in developing countries, then placebo-controlled trials are appropriate. This page was last edited on 11 Novemberat The welfare of animals used for research must be respected. After consultation, which included expressions of concern, [68] a final rule was issued on April 28, replacing the Declaration of Helsinki with Good Clinical Practice effective October Ethical Principles For Medical Research.

Justification was provided by a WHO group in Geneva which concluded ” Placebo-controlled trials offer the best option for a rapid and scientifically valid assessment of alternative antiretroviral drug regimens to prevent transmission of HIV “.

Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.

Historical and contemporary perspectives.

The most controversial revisions [39] Articles 29, 30 were placed in this new category. Vulnerable Groups and Individuals Foreign clinical studies not conducted under an investigational new drug application. Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.

University Publishing Group, Inc.

Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects. The research protocol must be submitted for consideration, comment, guidance and approval to helsingforsdeklarationn concerned research ethics committee before the study begins.


Indian Journal of Medical Ethics. All medical research subjects should be given the option of being informed about the general outcome and results of the study. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.

It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. Article 30 was debated further at the meeting, with another proposed clarification [50] but did not result in any convergence of thought, and so decisions were postponed for another year, [53] [54] but again a commitment was made to protecting the vulnerable.

Declaration of Helsinki – Wikipedia

Annals of Internal Medicine. Two troublesome paragraphs in the Declaration of Helsinki are causing a furore over medical research ethics”. All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.

Article 30 introduced another new concept, that after the conclusion of the study patients ‘should be assured of access to the best proven’ intervention arising from the study, a justice issue. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.

The US FDA rejected the and subsequent revisions, only recognizing the third revision, [58] and in announced it would eliminate all reference to the Declaration. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration.

Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards.


WMA revises the Declaration of Helsinki. In this sense the Declaration endorsed ethical universalism.

CODEX – regler och riktlinjer för forskning

When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. The third revision dealt further with the function and structure of the independent committee. Privacy and C onfidentiality This new role for the Declaration has been both denounced [18] and praised, [39] Macklin R. This consisted of a call for submissions, completed in August Surprisingly, although the wording was virtually unchanged, this created far more protest in this revision.

WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects

Lessons from the recent revision of the Declaration of Helsinki. Journal of Medical Ethics. In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions. Given the lack of consensus on many issues prior to the fifth revision it is no surprise that the debates continued unabated. The terms of reference included only a limited revision compared to The scope of ethical review was increased to include human tissue and data Article 1the necessity to challenge accepted care was added Article 6as well as establishing the primacy of the ethical requirements over laws and regulations Article 9.

The revision was almost twice the length of the original.

Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights. Public debate was relatively slight compared to previous cycles, and in general supportive. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research. This revision implies that in choosing a study design, developed-world standards of care should apply to any research conducted on human subjects, including those in developing countries.

It is not a legally binding instrument under the international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians.